- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02519790
Optimizing Medication Management for Mothers With Depression (OPTI-MOM)
Study Overview
Status
Conditions
Detailed Description
The overarching goal of this The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) funded U54 Obstetric-Fetal Pharmacology Research Center study is to develop evidence to construct guidelines for the optimal use of selective serotonin reuptake inhibitor (SSRI) antidepressants in pregnant women. The progressive changes in plasma SSRI and metabolite concentrations across pregnancy and after birth will be determined in an observational study. Serial evaluations of depressive and anxiety symptoms and side effects will be obtained to evaluate their association with plasma concentrations at monthly intervals during pregnancy and twice post-birth. To assess the subjects' metabolic phenotypes, subjects have the option to receive a probe drug cocktail, which will be given to evaluate the activities of enzymes involved in antidepressant metabolism during the third trimester (when activity change is maximal) compared to the non-pregnant state after birth.
Additionally, the study team will investigate the impact of genomic variability on inter-individual differences in SSRI dosing, plasma concentrations and pharmacodynamics during pregnancy, with a focus on genes involved in the metabolism and elimination of SSRIs, drug transporters responsible for SSRI access to the central nervous system, and genes encoding critical SSRI targets involved in therapeutic efficacy.
Finally, the study team will determine the maternal-fetal plasma concentrations and pharmacogenetic characteristics associated with neonatal SSRI abstinence syndrome. Maternal and fetal genotypes will be assessed for their relationship to SSRI drug concentrations and neonatal abstinence syndrome.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Northwestern University Asher Center for the Study and Treatment of Depressive Disorders
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
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Texas
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Galveston, Texas, United States, 77555
- University of Texas Medical Branch
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Wisconsin
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Marshfield, Wisconsin, United States
- Marshfield Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18-45
- Pregnant, less than or at 18 weeks gestation
- English-speaking
- DSM-IV diagnosis of Major Depressive Disorder (MDD), any subtype
- Medically healthy
- Singleton gestation
- Taking sertraline (Zoloft), fluoxetine (Prozac), or citalopram (Celexa)/escitalopram (Lexapro) and have made the decision to continue this medication throughout pregnancy
Exclusion Criteria:
- DSM-IV diagnosis of bipolar disorder or any psychotic episode
- Substance abuse or dependence in the last 6 months and/or positive urine drug screen
- Primary anxiety disorder without MDD
- EPDS score ≥15, or item 10, self-harm thoughts, is scored 3 "yes, quite often"
- Current use of other therapies for depression, including herbals (such as St. John's Wort)
- Chronic use of drugs for medical disorders except aspirin
- Allergy or adverse reaction to dextromethorphan, omeprazole, midazolam or tolbutamide (exclusion for probe study only; these individuals may still participate in the main study)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Concentration-to-dose ratio of SSRI in plasma
Time Frame: Every 4 weeks in pregnancy, at delivery, and at 6 and 14 weeks postpartum
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Every 4 weeks in pregnancy, at delivery, and at 6 and 14 weeks postpartum
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Edinburgh Postnatal Depression Scale (EPDS) Scores
Time Frame: Every 4 weeks in pregnancy, at delivery, and at 6 and 14 weeks postpartum
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Every 4 weeks in pregnancy, at delivery, and at 6 and 14 weeks postpartum
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Asberg Side Effects Scale
Time Frame: Every 4 weeks in pregnancy and at 6 and 14 weeks postpartum
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Every 4 weeks in pregnancy and at 6 and 14 weeks postpartum
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Katherine L. Wisner, M.D., M.S., Northwestern University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1U54HD085601-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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